Recalls / Class II
Class IID-0212-2026
Product
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02.
- Brand name
- Zinc Oxide 20%
- Generic name
- Zinc Oxide
- Active ingredient
- Zinc Oxide
- Route
- Topical
- NDC
- 69396-086
- FDA application
- M016
- Affected lot / code info
- Lot #: A502404, Exp. Date 2/27; A502405, Exp. Date 2/27; AS02502, Exp. Date 2/28.
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Blossom Pharmaceuticals
- Manufacturer
- Trifecta Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Plot No. 21/22 Bardez Blossom Pharmaceuticals Karaswada-Tivim, Bardej, Goa, N/A, India
Distribution
- Quantity
- 33000 containers
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2025-10-31
- FDA classified
- 2025-12-02
- Posted by FDA
- 2025-12-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0212-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.